Dosage and administration
adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Tamper Evident: Do not use if imprinted seal under cap is missing or broken. store at controlled room temperature
Simethicone 125 mg
Anti-Gas
for the relief of pressure, bloating, and fullness commonly referred to as gas
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, sorbitol special, titanium dioxide, water
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57896-792-05 | 2020-12-22 | C162847 | 48780-1 | 9d75b9cf-ec87-f424-e053-dadaa90a57ce | gc792 |
| 57896-792-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ec87-f424-e053-dadaa90a57ce | gc792 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-792-05 | EA - Each | 57896-792 | aeed7bbf-f4c1-41f1-ac70-89f3560e1e2f | 1 | 2019-05-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57896-792 | 57896-792-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN | 2G86QN327L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| MANNITOL | 3OWL53L36A | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b672ffef-4448-752e-e053-2995a90a6cb0 | 6130f5d8-9e89-32f6-e053-2a91aa0aba87 | 2020-12-14 | Warnings | 6130f5d8-9e89-32f6-e053-2a91aa0aba87 |
Adverse event summaries are temporarily unavailable. Other product information remains available.